Safety of intranasal insulin administration in patients undergoing cardiovascular surgery: An open-label, nonrandomized, dose-escalation study.

ABSTRACT:

Objective

This study aimed to determine the maximum safe dose of intranasal insulin administration during cardiac surgery.

Methods

This open-label, Phase 1, single-center, dose-escalation clinical trial recruited patients scheduled to undergo elective cardiac surgery or major vascular surgery requiring cardiopulmonary bypass between February and September 2021. They were grouped into 5 dose-escalation cohorts and administered 0, 40, 80, 160, and 240 IU insulin (n = 6 in each group) via a metered nasal dispenser after the induction of general anesthesia. Blood samples were collected at 10-minute intervals for the first 60 minutes and at 30-minute intervals thereafter. Hypoglycemia was defined as a blood glucose level <70 mg/dL. Patient recruitment was terminated after hypogly

SUBMITTER: Nakadate Y 

PROVIDER: S-EPMC10897660 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature